An observational study in Fever Malaria, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 1 site in India. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2021-03-10.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational
The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care (POC) setting in malaria endemic areas in India. Performance will be assessed in comparison with expert microscopy as the reference test for malaria, and with a high quality, commercially available C-Reactive Protein (CRP) test kit run on a laboratory machine as a reference test for CRP.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 1,808 is above the median of 600 across 218 observational studies indexed under Malaria.
Browse Malaria studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 5 years and above with clinically suspected malaria on the basis of fever or history of fever in the previous 72 h, either enrolled by passive case detection in health care facilities, or by active case detection in the surrounding communities.
Exclusion Criteria:
Testing with a malaria/CRP combination test, in parallel with a standard malaria RDT (to guide case management), preparation of thin/thick films for expert malaria microscopy, and collection of venous blood for subsequent CRP quantification.
Clinical performance of the Malaria/CRP combination test for malaria diagnosis at day 0
Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the diagnosis of malaria, in comparison with expert microscopy as the reference test at day 0 (first day of presentation).
Time frame: Day 0
Clinical performance of the Malaria/CRP combination test for detection of high levels of C-reactive protein at day 0
Point estimates (with 95% confidence intervals) of the sensitivity, specificity, positive and negative predictive values of the STANDARD™ Q Malaria/CRP Duo Test for the detection of CRP at day 0, in comparison with the CRP-LX reagent kit used with the Roche Diagnostics Cobas™ c111 chemistry analyser, or equivalent, as the reference test.
Time frame: Day 0
Plan to share: No
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland